CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Pentostatin +4 moredrug
Likely dose
Pentostatin 8mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00402714
NCT00402714Phase 2Completed

A Randomized Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation Versus Pentostatin and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies

Yale University·interventional·Posted Nov 22, 2006·Updated Jan 18, 2017

In Brief

A Phase 2 clinical trial evaluating extracorporeal photopheresis, Pentostatin, and 1 other intervention for Hematologic Malignancies. Completed, enrolled 14 participants across 3 sites.

Detailed Summary

This is a study to explore the use of a reduced intensity transplant conditioning regimen. A conditioning regimen is the treatment that is given to prepare a body for the new bone marrow that will be received from a donor. Reduced intensity conditioning uses lower doses of chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and radiation cause fewer side effects. Reduced intensity regimens have been offered to older patients or patients at increased risk for transplant-related side effects and have been shown to be safe and effective. Reduced intensity conditioning regimens are now considered for many patients who are undergoing transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2006
Enrollment StartJul 1, 2006
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.6 years ago

Interventions

extracorporeal photopheresisprocedure

Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.

Pentostatindrug

pentostatin 8mg/m2 over 48 hours by continuous infusion

Total Body Irradiationradiation

600cGy TBI in 3 200cGy TBI fractions

Pentostatindrug

pentostatin 8mg/m2 over 48 hours by continuous infusion

Total Body Irradiationradiation

600cGy TBI in 3 200cGy TBI fractions